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Background

Assisted reproduction is increasingly available to infertile and subfertile couples in the developed countries and in many developing countries (also referred to as "low resource settings"). Correspondingly, the sophisticated treatment regimens associated with assisted reproduction are being applied to an expanding population of otherwise healthy infertile couples.

As a result, questions have been raised on the effectiveness, safety, availability, and costs of these procedures, as well as on the many ethical and legal aspects of their use. It is therefore understandable that the practice of assisted reproduction and its clinical outcomes have been reported extensively in the literature during the last decade. It appears, however, that most of these reports have come from individual clinical centers and are based on relatively small numbers of patients. Therefore, the applicability of specific results and outcomes from such small and highly selected patients to the general populations seeking treatment is limited.

During its infancy, assisted reproduction was developed and was only available at a small number of specialized research institutions worldwide. Individual clinical experiences could be exchanged through the scientific literature, international conferences, or informal exchanges among the well-known clinical centers. With the expansion of both the number of clinics providing these techniques and number of patients receiving treatment, more rigorous data collection has become necessary.

Data Collection Rationale

To better understand the scope and impact of assisted reproduction, public health agencies and medical societies worldwide have established or soon will establish national surveillance systems of these technologies.

The collection of data on the outcomes and possible adverse effects of assisted reproductive techniques can assist:

  1. Patients seeking medical assistance for their infertility by allowing them to make informed and appropriate decisions concerning their own treatment options.
     
  2. Public health authorities responsible for assuring public safety, developing health care delivery policies, and ensuring cost reimbursement.
     
  3. The medical profession in providing optimal patient care by advancing the research and development of more effective forms of treatment while documenting the effectiveness of currently available techniques.

The collection and pooling of data on assisted reproduction occurs at different levels for different purposes:

  1. Individual centers collect data for monitoring their own procedures, for research purposes within their own clinic, as a basis for information to their patients, and as a basis for publication of results.
     
  2. National registries are increasing in number since they enable countries to summarize the total experience of all identified clinics performing assisted reproduction. Such programs avoid the difficulties in interpreting the results of a small number of clinics performing, for example, limited forms of assisted reproduction on relatively small numbers of patients. Furthermore, an individual clinic can compare its practice and treatment outcomes with others within its country.
     
  3. International data collection programs have been performed largely as multicenter epidemiologic studies rather than as multinational registry programs. International data collection and analysis for research studies primarily serves the purpose of identifying rare but very important events, where even national programs often are restricted.
     
  4. An international registry is important to describe the worldwide use of ART according to availability, efficacy, safety, and to identify similarities, differences, and trends.

Data Collection Methodology

Data collection and data handling can be done following either of two strategies:

  1. The national collection and analysis of clinic result summaries, which is a reasonably inexpensive and simple way to record a number of defined events such as the proportions of successful treatment cycles, the proportion of abortions, the proportion of ectopic pregnancies, etc. Each center then usually operate with its own type of data collection and only gives a yearly summary report. The disadvantage of such strategy is that it gives no opportunities to trace significant reasons for outcomes within the system so only general trends in the previously defined events can be followed over time.
     
  2. The centralized collection of data from all individual treatment cycles started in all centers within one country is a more difficult and expensive approach requiring a larger staff of professionals centrally for data handling. It also requires that the individual centers be required or agree to conform to use a uniform data system. The resulting registry adds considerable advantages to the simple strategy described above since it will give opportunities for research on multiple factors influencing selected outcomes of interest.

Australia, New Zealand, and Sweden are examples of countries that have chosen the first alternative, whereas the UK, Germany, and France are examples of countries that have chosen to follow the second strategy. The USA initially adopted the first strategy, but for two decades has used the second approach. It is obvious that the second strategy leads to a more sophisticated capability of answering relevant questions, as outlined above, but the cost-effectiveness of the alternate efforts must be considered.

The publication of data needs to meet justified demands on data availability to the profession and to the public. The information needs to be interpreted and presented with relevant professional comments to avoid misinterpretation. Publication of crude (unadjusted) pregnancy rates from individual centers alone can not be the primary goal of an international registry. Indeed, such presentations may not be in the best interest of the public.

A major accomplishment of any international working group, therefore, should be to define standard definitions and methods for presenting information, thereby facilitating interpretation and inference. ICMART has done this most recently in cooperation with the World Health Organization (WHO), to whom ICMART is a technical advisor.
 

ICMART Officers

Board Members

Regional Representatives

Honorary Past Chair

  • Paul Lancaster, MD

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